FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR RF
MDR report key: 3923107
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14437
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- May 1, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ATRIAL LEAD REVISION, THE PULSE GENERATOR EXHIBITED BACKUP VVI MODE AND A PREMATURE ELECTIVE REPLACEMENT INDICATOR. ELECTROCAUTERY INTERACTION WAS SUSPECTED. DURING A SOFTWARE DOWNLOAD ATTEMPT, THE DEVICE EXHIBITED LOSS OF TELEMETRY AND LOSS OF OUTPUT. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401750 | ACCENT DR RF | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | (B)(4) |